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| ID | Type | Description | Link |
|---|---|---|---|
| FORWARD | Other Identifier | Allergan |
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This study will evaluate the efficacy, safety and tolerability of prophylactic (preventative) treatment with BOTOX® (onabotulinumtoxinA) compared to topiramate in adults with chronic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BOTOX® | Active Comparator | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. |
|
| Topiramate | Active Comparator | Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| onabotulinumtoxinA | Biological | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days | Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported. | Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Frequency of Headache Days Per 28-day Period | Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Esther Jo | Allergan | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Joseph's Hospital Barrow Neurology Clinics | Phoenix | Arizona | 85013 | United States | ||
| North County Neurology Associates |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32985341 | Derived | Blumenfeld AM, Patel AT, Turner IM, Mullin KB, Manack Adams A, Rothrock JF. Patient-Reported Outcomes from a 1-Year, Real-World, Head-to-Head Comparison of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. J Prim Care Community Health. 2020 Jan-Dec;11:2150132720959936. doi: 10.1177/2150132720959936. | |
| 31559634 |
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| ID | Title | Description |
|---|---|---|
| FG000 | BOTOX® | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. |
| FG001 | Topiramate/BOTOX® | Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment 1 |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 17, 2017 | May 7, 2018 |
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| Topiramate | Drug | Topiramate up to a maximum oral dose of 100 mg/day. |
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| Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 |
| Change From Baseline in Headache Impact Test (HIT-6) Total Score | The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a "best to worst" scoring. A negative change from Baseline (a lower score) indicates improvement. | Baseline (Day 1) to the last 28-day period ending with Week 30 |
| Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days | Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported. | Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 |
| Encinitas |
| California |
| 92024 |
| United States |
| California Headache and Balance Center | Fresno | California | 93723 | United States |
| Newport Beach Clinical Research Associates, Inc. | Newport Beach | California | 92663 | United States |
| Denver Neurological Clinic | Denver | Colorado | 80210 | United States |
| Ki Health Partners LLC DBA New England Institute for Neurology and Headache | Stamford | Connecticut | 06905 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton Inc | Boca Raton | Florida | 33486 | United States |
| Design Neuroscience Center | Doral | Florida | 33172 | United States |
| NW FL Clinical Research Group, LLC | Gulf Breeze | Florida | 32561 | United States |
| Negroski, Sutherland & Hanes Neurology | Sarasota | Florida | 34239 | United States |
| Neurology Research Institute at Palm Beach Neurology | West Palm Beach | Florida | 33407 | United States |
| Robbins Headache Clinic | Riverwoods | Illinois | 60015 | United States |
| International Clinical Research Institute Inc | Overland Park | Kansas | 66210 | United States |
| Kansas City Bone and Joint Clinic | Overland Park | Kansas | 66211 | United States |
| The NeuroMedical Center | Baton Rouge | Louisiana | 70810 | United States |
| MedVadis Research Corporation | Watertown | Massachusetts | 02472 | United States |
| New England Regional Headache Center Inc | Worcester | Massachusetts | 01605 | United States |
| Allegiance Health | Jackson | Michigan | 49201 | United States |
| Clinvest | Springfield | Missouri | 65807 | United States |
| Mercy Health Research | St Louis | Missouri | 63141 | United States |
| Renown Institute for Neurosciences | Reno | Nevada | 89502 | United States |
| Dent Neurosciences Research Center Incorporated | Amherst | New York | 14226 | United States |
| Island Neurological Associates PC | Plainview | New York | 11803 | United States |
| Montefiore Headache Center | The Bronx | New York | 10461 | United States |
| Asheville Neurology Specialists PA | Asheville | North Carolina | 28806 | United States |
| Headache Wellness Center | Greensboro | North Carolina | 27405 | United States |
| Raleigh Neurology Associates PA | Raleigh | North Carolina | 27607 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Preferred Primary Care Physicians | Pittsburgh | Pennsylvania | 15236 | United States |
| Main Line Health Lankenau Hospital | Wynnewood | Pennsylvania | 19096 | United States |
| Texas Neurology | Dallas | Texas | 75214 | United States |
| Puget Sound Neurology | Tacoma | Washington | 98409 | United States |
| Rothrock JF, Adams AM, Lipton RB, Silberstein SD, Jo E, Zhao X, Blumenfeld AM; FORWARD Study investigative group. FORWARD Study: Evaluating the Comparative Effectiveness of OnabotulinumtoxinA and Topiramate for Headache Prevention in Adults With Chronic Migraine. Headache. 2019 Nov;59(10):1700-1713. doi: 10.1111/head.13653. Epub 2019 Sep 26. |
| COMPLETED |
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| NOT COMPLETED |
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| Treatment 2 |
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Intent-to-treat (ITT) Set included all randomized participants.
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| ID | Title | Description |
|---|---|---|
| BG000 | BOTOX® | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. |
| BG001 | Topiramate | Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. Participants who discontinue topiramate are eligible to receive treatment with BOTOX®. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Height | Mean | Standard Deviation | centimeter (cm) |
| |||||||||||||||
| Weight | Mean | Standard Deviation | kilogram (kg) |
| |||||||||||||||
| Body Mass Index (BMI | Mean | Standard Deviation | kg/m^2 |
| |||||||||||||||
| Use of Headache Prophylactic Treatment(s) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants With a ≥ 50% Decrease From Baseline in the Frequency of Headache Days | Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 50% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported. | ITT Set included all randomized participants. | Posted | Number | percentage of participants | Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 |
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| Secondary | Change From Baseline in the Frequency of Headache Days Per 28-day Period | Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. A negative change from Baseline (less headache days) indicates improvement. | ITT Set included all randomized participants. | Posted | Mean | Standard Deviation | days | Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 |
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| Secondary | Change From Baseline in Headache Impact Test (HIT-6) Total Score | The HIT-6 is a valid disease-targeted measure used to assess the impact of headaches, comprised of 6 items that assess pain, role functioning, social functioning, cognitive functioning, vitality, and psychological distress. A total score is created by summingacross all items, and ranges from 36 (no impact) to 78 (severe impact) reflecting a "best to worst" scoring. A negative change from Baseline (a lower score) indicates improvement. | Participants from the ITT Set, all randomized participants, with data available for analysis. | Posted | Mean | Standard Deviation | score on a scale | Baseline (Day 1) to the last 28-day period ending with Week 30 |
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| Secondary | Percentage of Participants With a ≥ 70% Decrease From Baseline in the Frequency of Headache Days | Participants recorded their headaches in a daily e-diary. A headache day was defined as a calendar day (00:00 to 23:59) with 4 or more hours of headache and/or headache of any duration with the use of migraine-specific acute headache medication(s). The number of headache days over the 28-day period was counted. The percentage of participants with a ≥ 70% decrease in headache days in the 28-day period prior to Week 32 relative to Baseline (28-day period prior to Day 1) is reported. | ITT Set included all randomized participants. | Posted | Number | percentage of participants | Baseline (First 28 days from Screening) to the last 28-day period ending with Week 32 |
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First dose of study drug to the final visit (Up to 48 Weeks)
Adverse Events (AEs) were counted in the treatment group based on investigator's determination. If investigators determined AE was related to both treatments or relatedness was unknown, it was counted in both treatment groups, but only once for the total population.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BOTOX® | 155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks for up to 3 treatments. The 80 participants originally treated with topiramate who then received BOTOX® are included in this arm. | 0 | 220 | 4 | 220 | 27 | 220 |
| EG001 | Topiramate | Topiramate starting at a daily oral dose of 25 mg/day titrated up to a maximum dose of 100 mg/day for 36 weeks. | 0 | 142 | 6 | 142 | 89 | 142 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial tachycardia | Cardiac disorders | MedDRA 17.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Deep vein thrombosis | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Invasive lobular breast carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 17.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 17.0 | Systematic Assessment |
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| Peripheral arterial occlusive disease | Vascular disorders | MedDRA 17.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Road traffic accident | Injury, poisoning and procedural complications | MedDRA 17.0 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vision blurred | Eye disorders | MedDRA 17.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 17.0 | Systematic Assessment |
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| Paraesthesia | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Cognitive Disorder | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Distubance in attention | Nervous system disorders | MedDRA 17.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 17.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 17.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 17.0 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 17.0 | Systematic Assessment |
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A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Allergan, Inc | 714-246-4500 | clinicaltrials@allergan.com |
| SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | May 27, 2014 | May 7, 2018 | Prot_001.pdf |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D007661 | Ketoses |
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| 25 to <35 |
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| 35 to <45 |
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| 45 to <55 |
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| ≥55 |
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| Male |
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| Black |
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| Asian |
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| Hispanic |
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| Other |
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| Participants |
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